RxSight Light Adjustable Lens and Light Delivery Device
FDA premarket approval P160055/S005 · decided 2019-08-06
Approval details
- PMA number
- P160055
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RxSight Light Adjustable Lens and Light Delivery Device
- Generic name
- Light adjustable lens (LAL) and light delivery device (LDD)
- Applicant
- Rxsight, Inc.
- Date received
- 2019-05-08
- Decision date
- 2019-08-06
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- PZK
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- Approval for the addition of a barcode scanner, internalization of the (optional) external LDD camera and update to the red reticle to enhance LAL visualization and alignment monitoring (called Align Assist), addition of an alternate supplier and model for the system computer and graphics card, and modification to LDD table legs to meet pinch point IEC 60601-1 testing requirements.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RxSight® Insertion Device (K261174) | Rxsight, Inc. | 2026-06-10 |
| RxSight® Insertion Device (63002) (K231838) | Rxsight, Inc. | 2023-08-15 |
| RxSight Insertion Device (K231466) | Rxsight, Inc. | 2023-06-12 |
| RxSight Contact Lens (K201909) | Rxsight, Inc. | 2020-09-10 |
| RxSight Insertion Device (K192926) | Rxsight, Inc. | 2020-01-17 |
| RxSight Insertion Device (K181401) | Rxsight, Inc. | 2018-07-26 |